Updates to the Common Rule: Harmonizing the Protection of Human Subjects With Research in a New Era

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These days, researchers and research consumers alike take for granted the idea that people who participate in research projects should be treated ethically. However, the guidelines that provide the standard boundaries in which researchers operate undergo regular scrutiny and are continually evolving. Since 1991, the Federal Policy for the Protection of Human Subjects, also referred to as the “Common Rule,” has been a regulatory requirement for institutions that conduct research sponsored by any one of 16 federal agencies. The Common Rule has been the standard for human subjects protection in the United States. To understand the rationale underlying some of the recent changes to the Common Rule, it is valuable to know a bit about its origins.
The chief guiding principle of all human subjects research is that the welfare of the participant is the investigator's primary obligation. Central to this principle is respect for the participants, their right to make their own decisions regarding research participation, and their right to the information needed to make these decisions. The ethical foundations of human subjects research can be traced to Nuremberg Code of 1947, which was created in response to the atrocities of World War II. In June 1964, in Helsinki, Finland, the 18th General Assembly of the World Medical Association adopted a series of articles that enlarged the depth and scope of ethical guidelines available to researchers. Since 1964, the Declaration of Helsinki has been amended or clarified 9 times. The first amendment, in 1975, established the concept that an independent committee should have responsibility for providing oversight to research studies, giving rise to the institutional review board (IRB). The articles of the Declaration of Helsinki form the backbone of the Common Rule in the United States, as well as human subjects protection regulations in most developed countries.
Changes to the Common Rule were prompted by the tremendous recent evolutions in the way research is conducted, increases in the size and number of research studies, changes in the types of institutions involved in research, and transformations brought about by the capacity for digital data acquisition and transmission. On January 19, 2017, updates to the Common Rule were published in the Federal Register.1 These updates, which take effect beginning in 2018, followed a 1-year period in which the proposed changes were open for public commentary. The final version of the Common Rule reflects the input of the scientific community, as some of the proposed changes were not included in the final version.2 As an example, among the proposed changes that was not implemented on the basis of feedback from the community was a stipulation that consent be obtained from participants prior to use of their biological specimens, such as blood, saliva, and tissue, that were not linked to the individual (ie, nonidentified). For this reason, the current practice allowing use of these specimens without the need to obtain consent remains in effect.
Among the most salient changes implemented is the requirement that the consent form begin with a clear, comprehensible explanation of the study, including the risks and benefits, and available alternatives. This provision is a response to the growing complexity and “legalese” of the language being used in consent forms. Some of the changes to the Common Rule will improve the efficiency of the IRB oversight. The updated rule provides a clear recognition that studies do not all have the same level of risk. For example study that involves responding to a confidential questionnaire has a substantively different risk level than a study that involves an experimental intervention.
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